Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2— 510(k) K240849

Substantially Equivalent

Ambu A/S

FDA 510(k) clearance K240849 for Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2, Substantially Equivalent on 2024-10-16. Applicant: Ambu A/S.

Clearance details

Applicant: Ambu A/S
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2024-03-27
Decision date: 2024-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballerup, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.